At a glance
ClinicalIndex Comparison Record- ✓Age 12 to <24 months at consent
- ✓Healthy toddler as determined by clinical assessment, medical history, and clinical judgment
- ✓2 infant doses of Prevenar 13 prior to 12 months of age
- ✕History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis)
- ✕Major known congenital malformation or serious chronic disorder
- ✕Other chronic medical or laboratory abnormality that may increase risk or make participant inappropriate for study
- ✕Previous vaccination with any investigational pneumococcal vaccine or planned receipt through study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13
In Brief
A Phase 3 clinical trial evaluating 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine for Pneumococcal Disease. Completed, enrolled 356 participants across 43 sites in 3 countries.
Detailed Summary
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. This study is being conducted in children who: * are between 12 to 23 months of age; * are healthy as determined by the study doctors; * have received 2 doses of Prevnar 13 during the first year in life. Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.
Study Details
Timeline
Interventions
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine